14 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m
IVAN
TRAIMAK
/STOCK.ADOBE.COM
Analytics
O
ver the past decade, process analytical technologies
(PAT) for biopharmaceuticals have continued to evolve
as a way to improve process and product understand-
ing and ensure product quality. Biopharma PAT has
gone through distinct phases, from parameter monitoring using near
infrared (NIR) and ultraviolet spectroscopy, to process-state moni-
toring and estimation using multivariate analysis and Raman and
other spectroscopic methods, according to José C. Menezes, CEO of
4Tune Engineering Ltd. (1).
Within the past five years, a trend has developed to connect pro-
cess condition monitoring to accurate product quality control during
manufacturing, according to Menezes. Enabling this approach, he
says, has been the use of in-situ mass spectroscopy, and, specifically,
an approach called multiple attribute monitoring (MAM) that FDA
has included in its portfolio of emerging technologies.
MAM offers a unified, orthogonal approach for monitoring critical
quality attributes in complex biopharmaceuticals such as monoclonal
antibodies. Some of these impurities stem from post-translational
modifications and degradation during manufacturing and storage.
Others might be due to different manufacturing processes or differ-
ences in clone selection or storage, said Joseph Josephs, director of
Thermo Fisher's pharma and biopharma customer solutions center
in an October 2018 webcast produced by BioPharm International (2).
Examples of effects include lysine clipping, deamidation, and isom-
erization, he said, and MAM allows developers to monitor all these
effects in a more efficient way than was possible in the past. "Safety
is always the biggest concern, but changes due to post-translational
modifications can also affect potency, and we need to understand
Multiple Attributes
Monitoring: A New Phase in
PAT for Biopharmaceuticals
By reducing the number of
assays needed and allowing
product quality attributes to
be measured end to end,
MAM promises to allow users
to gain product and process
understanding much sooner
than they could in the past,
and to ensure quality and
safety in a more efficient,
streamlined way, throughout
the product life cycle.
Agnes Shanley
